Author Archives: BPI Contributor

Evaluation of the “Scale-Out” Biomanufacturing Strategy from Early Clinical Stage to Commercialization

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This webcast features: Jie Chen, MD, MS, Vice President of CMC Management, WuXi Biologics   The success of therapeutic biologics over the past decades has reshaped the pharmaceutical industry landscape. From orphan to biosimilar to novel blockbuster drugs, the production demands can range from grams to metric tons of biopharmaceutical products each year. This diverse range in manufacturing scale coupled with thousands of biologics in the development pipeline, has had significant impact on the design of biologics production models.  Without…

November 3, 2017

A Novel Approach to Single-Use Design and Implementation

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This webcast features: Graeme Proctor, Product Manager, Single Use Technologies, Parker Hannifin Manufacturing Ltd Single use assemblies can frequently take in excess of 16 weeks from concept to customer delivery. Challenges around design, customisation, validation and qualification can create delays in implementation and increase time to market. Parker will present a novel approach to single use design and implementation, which can dramatically reduce lead times and increase delivery reliability without affecting flexibility or quality. Learn how to: Quickly and easily…

October 27, 2017

Sartorius Stedim Biotech Wins Frost & Sullivan Award for Customer Service Leadership in Bioanalytical Contract Testing

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Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, received the prestigious Frost & Sullivan’s 2017 European Customer Service Leadership Award for Bioanalytical Contract Testing Services. Presented at the Frost & Sullivan ceremony yesterday evening in London, UK, this award recognizes the unique product and service combination and enhanced customer satisfaction provided by Sartorius Stedim BioOutsource, SSB’s subsidiary based in Glasgow. The annual Frost & Sullivan Excellence in Best Practices Awards recognizes companies, processes, strategies, and executives…

October 24, 2017

Targeted Locus Amplification for Transgene Sequencing in rCHO Clones Expressing Therapeutic Lysosomal Enzyme

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This webcast features: Vishal Agrawal, PhD, Scientist II, Cell and Molecular Biology, Biomarin Pharmaceutical Inc. and Joseph Abad, Field Applications Scientist, MaxCyte. Transgene site of integration dictates clonal stability and the long term transcriptional activity of gene of interest in recombinant CHO cells. In this presentation, we will discuss the application of targeted locus amplification (TLA) technology to identify genomic sites of transgene integration and integrity of transgene sequence itself to assess the suitability of recombinant CHO clones as a…

October 20, 2017

PCT Establishes Global Contract Development and Manufacturing Services Platform with Opening of Yokohama, Japan Facility

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Hitachi Chemical Co., Ltd. (HCC), a global service provider for the cell therapy industry through its PCT development and manufacturing service platform, today announced the completion of construction and opening of its Yokohama, Japan facility on October 11. This facility, as well as the existing two U.S. PCT facilities, will share the same global PCT service platform for quality and information systems, manufacturing operations, and technology transfer protocols, ensuring a seamless approach to serving clients and accelerating creation of a…

October 19, 2017

Bioprocessing in a Time of Digital Transformation

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eve® is a modular software system for bioreactors and incubator shakers, rethinking bioprocess control to meet the needs of modern users: Fast, secure access to data via a web browser from anywhere, using a range of devices The move to Big Data Analytics for process data analysis A single platform for different types of information required by different users e.g. researchers, production and quality assurance A browser-based approach to accessing this information makes considerations such as operating system, size of…

October 19, 2017

Fast Trak Education and Training 2017

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Gain specialist knowledge in bioprocessing With our Fast Trak education, you can access application training in specialized bioprocessing techniques. The courses provide a tangible learning experience for process development and manufacturing scientists, relevant to everyday work. Comprehensive training for your specific needs The Fast Trak courses cover various topics from upstream to downstream. These include cell culture, bioreactor scale-up, column packing, basic chromatography, as well as optimization and scale-up for both pilot and manufacturing scales. In addition to our standard…

October 17, 2017

Antibody Targeted Therapy Online Course

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This online module focuses on an intensive overview of the antibody therapeutics field, enabling you to: Gain a comprehensive understanding of the antibody field and awareness of the historical aspects, current research and future direction of the development of antibodies as therapeutics. Provide an overview of the antibody fields ranging from structure and function, through to the recent development of antibodies as therapeutics including manufacture and clinical development. Gain insights to some of the issues that are required to develop…

October 12, 2017

Cytonome Concludes Exclusive Sales Partnership Agreement with Inabata

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Cytonome/ST, LLC and Inabata & Co., Ltd. and have concluded an exclusive sales partnership agreement for Cytonome’s proprietary GigaSort® Technology in Japan. The GigaSort Platform is an application specific laser-based cell sorter that allows the identification, characterization, and isolation of highly purified cell populations. Due to its low pressure parallel microfluidic channel design, the GMP compliant GigaSort Platform provides high throughput processing while remaining gentle on cells. A fully enclosed, single use, fluidic set that contains a microfluidic chip solves…

October 12, 2017

Lonza Cell & Gene Therapy Manufacturing Facility in Houston, TX, Area to Complete Construction on Schedule in 2017

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Lonza confirmed today that its new cell and gene therapy manufacturing facility in Pearland, in the area of Houston, TX (USA), which started construction in 2016, is nearing completion and is on schedule to start production in Q1 2018, despite the storms that hit the state of Texas in late August and early September. The event organized around the opening of the facility has been moved into 2018 out of respect for the Lonza staff and people of Texas who…

October 11, 2017